MAUDE Adverse Event Report: SURMODICS INC SUBLIME¿ RADIAL ACCESS GUIDE SHEATH; Introducer, catheter

Model Number	SRA-GS35-6F120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	08/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A 6fr guide sheath was being used for left radial access during an atherectomy procedure.A radial drug cocktail was administered prior to the procedure start, to relax the target vessels.An ultrasound was not used to verify vessel diameter.The guide sheath was placed in the left radial artery to access the left leg.It was noted resistance was encountered during guide sheath placement.An orbital atherectomy system (oas) was used in conjunction with a balloon in the superficial femoral artery (sfa).It was reported that "everything looked good" until that point.During device removal, the patient had a vessel spasm, and the physician was unable to remove the sheath from the patient's left radial artery.The physician was using a 0.014" guidewire without a dilator.During the removal process, the sheath stretched and at one point the braids were exposed.Furthermore, the "sheath was no longer on and it was just the braid." at that time, the physician moved further down the sheath with hemostats and pulled with the hemostats approximately 5 cm at a time.This maneuver was repeated down the sheath until it could not be withdrawn anymore.The physician notified a surgeon, and the patient was brought to the operating room (or).A vessel cut down on the left radial artery was performed.The surgeon was unable to remove the sheath from the cut down, so the surgeon moved to the left brachial artery.A small incision was made at the left brachial artery and the surgeon was able to grab the sheath.The sheath was then cut so the surgeon could remove the remaining sheath in the descending aorta (physician wanted to remove the sheath from the bigger vessel first).Once the sheath was removed and the incisions were closed, the patient had palpable pulses.There was no further impact to the patient.The reported issue resulted in a procedure delay of approximately 30 - 45 minutes.
Additional Manufacturer Narrative
The guide sheath was returned for analysis.Analysis of the returned guide sheath found no anomalies that may have contributed to the reported issue.The guide sheath was returned in five segments.All damage to the segments were consistent with forcibly removing the guide sheath from the radial artery with hemostat markings evident every few centimeters.Segments 2, 3, and 4 showed extensive braid separation due to the amount of force needed to remove the guide sheath from the constricted artery.There was no indication the device did not perform as intended.

• Brand Name: SUBLIME¿ RADIAL ACCESS GUIDE SHEATH
• Common Device Name: Introducer, catheter
• Manufacturer (Section D): SURMODICS INC; 7905 golden triangle drive; suite 190; eden prairie, mn 55344 ; EI 55344
• Manufacturer (Section G): CREAGH MEDICAL; ida business park; creagh road; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: phil haney ; 7905 golden triangle drive; suite 190; eden prairie, MN 55344 ; 9525007598
• MDR Report Key: 17715808
• Report Number: 3014687026-2023-00006
• Device Sequence Number: 17829975
• Product Code: DYB
• UDI-Device Identifier: 05391525785165
• UDI-Public: 05391525785165
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K190644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2025
• Device Model Number: SRA-GS35-6F120
• Device Lot Number: 22201208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female